Catalog Number

-

Brand Name

Arterys MICA

Version/Model Number

AMM6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192437

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

444bb62b-6971-4f8d-a870-317fa56fe6a0

Public Version Date

July 13, 2020

Public Version Number

1

DI Record Publish Date

July 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-